DEERFIELD, Ill, April 15, 2010 – Baxter’s BioPharma Solutions business is completing its third capacity expansion at the company’s cytotoxic contract manufacturing facility in Halle (Westfalen), Germany. The facility has been expanded to meet clients’ needs for cytotoxic (oncology therapies) manufacturing, further enhancing Halle’s complete range of resources to support early phase drug formulation through commercial scale-up, introduction and lifecycle management.
The expansion includes upgrades across multiple specialized capabilities offered at the Halle facility. Most notably, a large-scale lyophilization unit was added for increased freeze-drying capacity, which supports a large majority of the Halle manufacturing business. This expansion, which will be completed by next month, has been designed to meet international manufacturing and regulatory requirements and will be followed by an additional phase of expansion to be completed by 2012.
Most of BioPharma Solutions’ clients require large-scale production services, primarily for commercially-marketed oncology drugs. To support these needs, part of the expansion project included replacing existing filling technology with a newer system, which will allow for a more than 50 percent increase in capacity for commercial cytotoxic manufacturing. The filling process uses advanced cRABS (closed Restricted Access Barrier System) technology for enhanced product sterility and operator safety. Baxter recently received the prestigious “Most Effective Scale-Up/Technical Transfer Award” at the 2009 European Outsourcing Awards for this project. The project was recognized for averting installation delays and maintaining manufacturing timelines to meet all client obligations during the expansion period.
Baxter also supports small-scale production, which is primarily used in clinical production, when clients are studying and seeking regulatory approval for new drugs. The facility now features a hand-fill suite, which is able to manufacture these small-scale clinical cytotoxic batches.
Another new Halle capability is commercial-scale production of cytotoxic emulsions, liposomes and suspensions, with the addition of a nanoparticle suite equipped with a high pressure homogenizer. These technologies allow Baxter to stay at the forefront of parenteral cytotoxic manufacturing.
“By offering a full complement of services in one location to support oncology drug production needs, we are able to meet clients’ growing needs for cytotoxic manufacturing in a single location, including early-to-late stage support to fully engage and service our clients throughout the lifecycle of their products,” said Dr. Burkhard Wichert, vice president of manufacturing for Baxter’s Halle facility.
The modern manufacturing site in Halle is equipped with industry-leading barrier isolator technology and is one of the most advanced facilities for cytotoxic contract manufacturing in the world. With more than 50 years of experience, the facility’s capabilities include lyophilization; process development; aseptic filling of cytotoxic, non-cytotoxic and highly potent liquid and sterile powder vials in clinical and commercial batch sizes; and sterile crystallization of cytotoxic active pharmaceutical ingredients. Learn more about the expansion by visiting the Baxter booth (booth #545) at Interphex in New York City, NY, from April 20 – 22, 2010 or at www.baxterbiopharmasolutions.com.
About Baxter
Baxter International Inc. (NYSE: BAX), through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
